Silicone Implants Expected To Return
August 21, 2006 -
When silicone breast implants were withdrawn from the market in 1992, many in the medical community thought they would never return. They may have been wrong. The return of the silicone breast implant now appears to be imminent.
The use of silicone implants never completely ended. For years, their use has been limited to breast reconstruction after mastectomy or clinical trials. Currently awaiting FDA approval, they may soon be available for general breast augmentation surgery.
The FDA is expected to approve silicone implants by the end of the year pending certain conditions. Silicone implant makers, Mentor and Inamed, will be required to meet the following conditions prior to approval:
- Market only to board certified plastic surgeons who have received proper training in the use of silicone implants
- Maintain a patient database to track leakage, rupture, or other problems reported with the implants
- Compel surgeons to obtain informed consent from patients
Silicone breast implants have long been the subject of much controversy and the source of numerous lawsuits. They have been accused of causing capsular contracture (development of scarring around the implant) and cited as possibly linked to various diseases.
However, saline implants also cause capsular contracture, and research has found no link between silicone implants and connective tissue disorders or life-threatening systemic illnesses.
Additionally, the new silicone implants will be made with thicker shells and more cohesive, less runny, gels.
The demand for breast implants has not waned over the years. In fact, it has steadily risen. One plastic surgeon predicts that the return of silicone breast implants will only lead to a greater demand.
“When (the FDA) release them for general use, I think you're going to see a huge upsurge in breast augmentation surgery,” said Dr. Brian Kinney, Los Angeles plastic surgeon.
Considering a breast augmentation? Please click here to locate a board certified plastic surgeon near you.
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